THROMBOKINETIC FIBRINOGEN ASSAY

System, Fibrinogen Determination

BIO/DATA CORP.

The following data is part of a premarket notification filed by Bio/data Corp. with the FDA for Thrombokinetic Fibrinogen Assay.

Pre-market Notification Details

• Device ID: K792563
• 510k Number: K792563
• Device Name: THROMBOKINETIC FIBRINOGEN ASSAY
• Classification: System, Fibrinogen Determination
• Applicant: BIO/DATA CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: KQJ
• CFR Regulation Number: 864.7340 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1979-12-12
• Decision Date: 1980-01-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
G0561009890	K792563	000